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A needle, not a scalpel: new device aims to create dialysis access in minutes

NCT ID NCT07786025

Disease control Sponsor: Distal Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial is testing a new device called DisTal that creates a connection between an artery and a vein in the arm—known as an arteriovenous fistula—without the need for surgery. The goal is to see if this minimally invasive procedure can successfully enlarge the vein at the access site within 100 days, as confirmed by ultrasound. The study involves 100 adults with end-stage kidney disease who require hemodialysis. If the procedure works, it could provide a faster, less invasive way to establish reliable dialysis access.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DisTal device – a catheter-based tool that creates an arteriovenous fistula (a connection between an artery and vein) in the arm without surgery, to provide a reliable access point for hemodialysis.
What this could lead to
If successful, this could offer a less invasive way to create dialysis access, potentially reducing surgery-related risks and recovery time for people with kidney failure.
What could go wrong
This is an early feasibility study, so the procedure may not work as intended or may cause complications like bleeding, infection, or damage to blood vessels. Success in this small group may not guarantee broader effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18. 2. End Stage Renal Disease (ESRD) requiring hemodialysis. 3. Having a patent cephalic vein at the wrist /forearm. 4. Signed informed consent. Exclusion Criteria: 1. Pregnancy or lactation. 2. Known central venous stenosis on the same side as the planned AVF creation. 3. Prior surgically created access in the planned treatment location. 4. Evidence of active infections at the time of study enrollment. 5. Known uncontrolled abnormal coagulation status and are at additional risk for clotting or excessive bleeding. 6. Prisoner. 7. Employee of the Sponsor.

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Conditions

The condition(s) this trial relates to.

end stage renal failure Fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage renal disease requiring haemodialysis

Contacts and locations

Locations

  • Clinica Canela

    La Romana, Dominican Republic

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